Analysis of Deposition With Nebulizers Membrane

Not Applicable

• Conditions: Healthy Volunteers
• Interventions: Device: phase 1 - jet nebulizer; Device: Phase 2- mesh nebulizer

• Registration Number: NCT02501655
• Lead Sponsor: Daniella Cunha Brandao

Brief Summary

BACKGROUND: Mesh nebulizers (MN) have lower residual volume and increased inhaled dose compared to jet nebulizers (JN) per in vitro and animal models. The aim of this study was to compare radioaerosol deposition using MN and JN in healthy subjects, using 2-D planar scintigraphy. METHODS: A randomized trial in 6 normal subjects (4 female, 2 male) inhaled 99mTc-DTPA with an activity of 1 mCi with the normal saline to a total dose of 4 mL with JN (Misty Max, Air Life, Yorba Linda, USA) oxygen flow of 8 L / min and 1.5 mL with MN (Aeroneb Solo with Ultra adapter; Aerogen Galway, Ireland). Scintigraphy was used to determine distribution of deposition and mass balance between compartments.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-07
• Study Start: 2015-07
• Study First Submitted: 2015-07-15
• Study First Submitted QC: 2015-07-16
• Last Update Submitted: 2015-07-16
• Study First Posted: 2015-07-17
• Last Update Posted: 2015-07-17
• Primary Completion: 2015-08
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• The study inclusion critera was healthy adults of both sexes, between 18 to 65 years, without history of lung disease or smoking, with forced vital capacity (FVC) or forced expiratory volume in the first second (FEV1) greater or equal to 80% of predicted values (Pereira et al., 1992), ability to follow and retain verbal commands while able and willing to provide signed consent to participate in this study.

Exclusion Criteria

• Participants were excluded if they have been diagnosed with a lung disease, current smoker, unable to understand and follow the procedures and pregnant or unable to tolerate nebulization.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Phase 2	phase 1 - jet nebulizer	Mesh nebulizers
Phase 1	Phase 2- mesh nebulizer	Jet Nebulizer - control group

Primary Outcome Measures

Name	Time	Method
radioaerosol deposition index into the lungs	1 month	Immediately after inhalation, participants sat in a chair with the back positioned in front to the gamma camera (STARCAM 3200 GE, California, USA) to obtain radioactivity counts from the posterior thorax during a period of 300 seconds on a matrix of 256 X 256. After, participants were positioned sitting in front to the gama camera to obtain images from face. Then, the same procedure was performed to analysis deposition in the nebulizer, circuits, inspiratory filter, expiratory filter and face mask. Counts representing stomach were obtained from posterior thorax and corrections for decay of technetium were used to during extrapulmonary measurements

Trial Locations

Locations (1)

Hospital das Clínicas de Pernambuco; 🇧🇷 Recife, Pernambuco, Brazil